# K201465: SuRgical Planner (SRP) BrainStorm

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Theater, Inc.
- Decided: Jul 17, 2020 after 45 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924630 (1993). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170793: SuRgical Planner (SRP), Surgical Theater, LLC (2018) Summary page 4.

## Most influential descendants
- K203486: Otoplan (2021), 2 descendants of its own
- K242120: Otoplan (2025), 0 descendants of its own
- K220300: Otoplan (2022), 0 descendants of its own
- K210344: inVisionOS (2021), 0 descendants of its own

## Recalls of this device
- Sep 16, 2025 · Class II · Z-0325-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer

## Indications for use
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.

Source page: https://510kreport.com/device/K201465
Methodology: https://510kreport.com/methodology